A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Completed · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

In brief

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Key facts

Study ID

NCT01643408

Run by

Jazz Pharmaceuticals

People needed

30

Starts

2012-11-01

Expected to finish

2013-12-01

Last updated by the study team

2021-06-23

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
• Ages >/= 1 and </= to 30 years at the time of initial diagnosis
• Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
• Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
• Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
• Direct bilirubin less than or equal to Grade 2
• Amylase and lipase within normal limits (per institutional standards)
• Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange County, California, United States
• Stanford Medical Center — Palo Alto, California, United States
• Children's Hospital — Aurora, Colorado, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• John Hopkins — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Michigan, United States
• Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota, United States
• UMDNJ/Robert Wood Johnson — New Brunswick, New Jersey, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Montifiore Medical Center — The Bronx, New York, United States
• Oregon Health & Sciences — Portland, Oregon, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Inova Fairfax Medical Center — Falls Church, Virginia, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• McMasters University Medical Center — Hamilton, Ontario, Canada
• Sick Children's Hospital — Toronto, Ontario, Canada
• Hospital St. Justine — Saint Catherine, Quebec, Canada
• Quebec Children's Hospital — Sainte-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

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